The American Urogynecologic Society (AUGS) has issued a position statement that pushes back against any restrictions to ban surgical options for the treatment of pelvic organ prolapse (POP), including transvaginal surgical mesh cleared for use by the U.S. Food and Drug Administration (FDA).
The AUGS position states that it is essential for patients and their surgeons to have access to a full range of both non-surgical and surgical options.
We have been talking for years about the complications suffered by women who were victims of this type of surgical repair:
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Without saying so in the group’s news release, there has been tremendous pressure to ban or severely restrict the use of polypropylene (PP) mesh due to the thousands of injured women who have filed lawsuits against the five major mesh manufacturers. So far these are product liability lawsuits that do not name the doctor for malpractice, but a few individual lawsuits do.
Last year a lawsuit against C.R. Bard named the doctor who implanted mesh in Christine Scott. The jurors in the California case blamed both Bard and the surgeon and awarded Scott and her husband $5.5 million. That award has been appealed.
There are at least 15,000 lawsuits filed naming the top five mesh manufacturers and many more are being filed in state court and federal courts every day.
As a result of all of the injuries, at least one state medical organization, a healthcare system and a medical malpractice insurance company have suggested restrictions be placed on use of the surgical mesh or an outright ban be placed on its use by doctors who refer to polypropylene mesh as a “gold standard.”
“Such restrictions were never the intent of the FDA safety communication nor do they represent the findings of the FDA Advisory Panel,” says AUGS in its press release.
In July 2011, the FDA said the benefits of surgical mesh repair may not outweigh the complications which are “not rare.”
Pelvic organ prolapse or POP is a condition that occurs when the normal support of the vagina is lost, resulting in sagging or dropping of the vagina, uterus, bladder and rectum. The FDA cleared the first transvaginal mesh for the treatment of POP in 2002. Previously the same mesh material was used to treat hernia patients.
Since then the agency has been receiving thousands of adverse event reports including chronic pain, nerve damage, infection, mesh migration and erosion from injured women.
In its statement AUGS implies that the bad outcomes may be due to surgeons who are not adequately trained so the medical society has developed credentialing guidelines to audit surgeons who perform these types of urogynecologic procedures and to establish processes to credential these surgeons.
The general guidelines include:
- Establish a broad group of trained pelvic floor reconstructive experts to review cases and complications of both mesh and non-mesh prolapse repair.
- Ensure appropriate resources and patient management systems are implemented to identify and manage both mesh and non-mesh related complications.
- Track both surgeons and specific products being implanted, as these may each influence efficacy and complications.
- Mandate a standardized informed consent process for mesh placement.
Almost across the board, we hear from women who had no idea of the complication rate (up to 30%), or the fact that this implant is intended to be permanent and only a few doctors in the country can remove it. They had no idea they might be made permanently disabled or suffer life altering complications.
A good pre-operative consultation must include all adverse events so a patient can make an informed consent. How many women would have agreed had they known all the facts?
The professional medical society does not address how a bad surgeon could be impacting mesh shrinkage or migration or the autoimmune reactions some patients experience when a polypropylene mesh is permanently implanted to treat pelvic organ prolapse or even hernias.
Finally, with all due respect, where has AUGS been between 2002 and today? Why have they not entered the controversy before and proposed strict training and guidelines?